Intrauterine medicator

ABSTRACT

An intrauterine medicator and method for local application of medication to the uterus. The medicator includes a perforated tube containing a supply of medication; apparatus for maintaining medication adjacent the perforations for distribution to the uterine wall, and apparatus resiliently retaining the device in the uterus.

United States Patent Rudel [4 1 Apr. 18, 1972 [54] INTRAUTERINE MEDICATOR 1,605,894 11/ 1926 Human .,128/271 2,623,841 12/1952 Taub ..128/127 X [72] Invent 2,962,023 1l/1960 Chappaz et a1. ..128/260 [73} Assignee: Biological Concepts, Inc., New York, NY, 3,409,721 11/1968 Applezwein ..128/130 Filed: J 1 FOREIGN PATENTS OR APPLICATIONS 1 1 MP 3,137 13,324 7/1894 Great Britain ..128/127 52 us. c1 ..128/264, 128/130 Primary Bummer-Robert Michell 511 1111. C1. ..A61m 31/00 Attorney-Curtis. Morris & Saffvrd [58] Field of Search ..128/264, 130,127, 265, 251,

128/270, 271, 263, 260, 26]; 901/81 ST CT 5 6 R f d An intrauterine medicator and method for local application of l 1 e erences l e medication to the uterus. The medicator includes a perforated UNITED STATES PATENTS tube containing a supply of medication; apparatus for maintaining medication adjacent the perforations for distribution 2,122,579 7/1938 Meckstroth ..128/l30 to h uterine ll, and a paratus'resiliently retaining the 3,442,266 5/1969 Kre1c1 et a1. ...128/130 device i h uterus 3,545,439 12/1970 Duncan ...128/130 1,603,767 10/1926 Harris 128/271 12 Claims, 6 Drawing Figures PATENTEDAPR 1 8 I972 I //l l/ INVENTOR.

Buclel 2%? ATTO rs INTRAUTERINE MEDICATOR The present invention relates to intrauterine medicator devices and in particular to intrauterine carries of medication for locally supplying medication to the uterine walls. One of the embodiments of the invention is directed to an intrauterine carrier of antifertility agents.

In the practice of medicine it has been found desirable to furnish certain'therapeutic and biologically active materials to the uterus by local rather than systemic administration of the drug. For example, certain biologically active materials such as progesterone and progestational compounds, which are known in the prior art as effective antifertility agents, have been administered systemically in the past with resulting undesirable side effects in certain patients. However, it has been found that these side effects can be avoided by locally supplying these agents to the uterine wall.

Specifically, progesterone and progestational compounds when supplied locally to the uterus produce changes in the endometrium which are characteristic of the biological action of the same progestational compounds given systemically. Such changes, characterized as premature maturation of the endometrium, are capable of significant antifertility effects and can be achieved with doses of progestational agents small enough not to inhibit ovulation.

While local administration of natural progesterone hormones has been attempted in the past, success has been achieved only by repeated and frequent applications.

It is an object of this invention to supply antifertility agents and other medication, locally, to the uterine wall. It is another object of the invention continuously to provide such medication over extended periods of time. Another object of the invention is to provide apparatus for retaining a container of medication in the uterus. A still further object of the invention is to provide a method for locally administering biologically active medication to the uterus. It is a further object of the invention to provide a simple and inexpensive intrauterine medicator device.

In accordance with the preferred embodiment of the present invention there is provided an intrauterine medicator having a perforated tube, such as of corrosion-resistant or coated metal, or of plastic, in which a supply of a medication, is enclosed. The drug is suitably in the form of individual pellets and is urged under the force of means, such as a com pressed spring, in the tube to a position adjacent the perforations. The tube is adapted to be inserted in the uterus so that body fluids can leach the medication from the tube through the perforations for local administration to the uterine wall. As the drug dissolves in the area of the perforations, the compressed spring pushes a new supply of the drug adjacent the perforations so that a continuous controlled release of the drug is obtained. The drug utilized in the medicator tube may be any therapeutic or biologically active material which is adapted to local administration; however, in the preferred embodiments an antifertility agent such as progesterone is utilized.

The medicator tube is retained in the uterus by a pair of generally inverted V-shaped springs, each having one leg fixed to the tube. The free leg of each spring extends beyond the tube and resiliently engages the uterine wall to maintain the position of the device in the uterus. In another embodiment the tube may be formed as part of a so-called intrauterine contraceptive device or IUD, such as the well-known Lippes Loop or other such devices. In this manner the tube of the present invention supplements the function of the IUD and is held thereby in position in the uterus.

The construction of the preferred embodiment as well as further objects and advantages thereof will become further ap-' parent from the following specification when considered in conjunction with the accompanying drawings wherein:

FIG. 1 is a perspective view of the intrauterine medicator of the present invention;

FIG. 2 is a plan view of the device illustrated in FIG. 1;

FIG. 3 is a view taken on line 3-3 of FIG. 2;

FIG. 4 is a perspective view of the intrauterine medicator contained within an instrument for insertion of the device into the uterus;

FIG. 5 is a view similar to FIG. 3, of another embodiment of the present invention; and

FIG. 6 is a front view of the medicator of the present invention formed as part of an intrauterine contraceptive device.

Referring now to the drawings, and in particular to FIG. 1, there is shown an intrauterine medicator 10 having spring retaining apparatus 12 which is adapted to maintain the medicator in position in the uterus.

Medicator 10 includes a cylindrical tube 14 having top and bottom ends 16 and 18 respectively. In the preferred embodiment tube 14 has a diameter of about l.5 2.0 millimeters and a length of about 2 centimeters. Ends 16 and 18 are closed by plates 20 and 22 respectively, which serve to retain a column of pellets 24 of a biologically active material, such as an antifertility agent, within tube 14.

The lower portion of tube 14 adjacent end 18 includes a plurality of perforations 26 through which the medicament is leached by body fluids within the uterine cavity. As individual pellets 24 dissolve, a new pellet will be moved into position adjacent perforations 26 by spring 28 to provide continuous release of medication. Spring 28 is a compression spring retained between the top plate 20 of tube 14 and bearing plate 30. Plate 30 is slidable within tube 14 and cooperates with spring 28 to push pellets 24toward perforations 26. In addition, plate 30 prevents mutilation of the uppermost pellet 24 by the end 29 of spring 28.

The number of perforations'26 and the size of pellets 24 may be correlated such that a single pellet will provide suffcient medication for a given period of time. The lowermost pellet 24a dissolves during the course of the desired time period and at the end of this period is weakened sufficiently so that it crumbles under the force of spring 28. Spring 28 then urges the entire column of pellets 24 downwardly towards lower end plate 22 whereby the next pellet, 24b in FIG. 2, is presented adjacent perforations 26 to again furnish the medication to the uterus for the desired time period. It is foreseen, for example, that the perforations 26 and the size and composition of pellets 24 may be correlated to an individual womens menstrual cycle so that a new pellet 24 is presented adjacent perforations 26 at the beginning of each cycle.

Pellets 24, as previously noted, are formed of a biologically active material. Such materials, in the preferred embodiment, include steroid hormones such as progesterone or related synthetic progestational compounds, estrogen, and testosterone, or other antifertility agents such as quinacrine, azauridine, or metallic copper grains. It is also foreseen that tube 14 can also carry therapeutic agents such as antibiotics for intrauterine treatments.

Intrauterine medicator 10 is maintained in position in the uterus by retaining apparatus 12 which includes a pair of inverted generally V-shaped spring members 32, which may be of metal, plastic, or some other resilient material. Each spring 32 has a pair of diverging legs 34 and 36 lying in parallel planes tangent to tube 14. Each leg 34 is fixed to the exterior surface of tube 14, for example, by adhesive, brazing, etc., and extends longitudinally therealong. Legs 36 are formed at an acute angle to legs 34 and diverge from one another to form a large inverted V as seen in FIG. 1.

When inserted in the uterus, the diverging free ends of legs 36 engage the uterine walls to retain the medicator in its proper position. Balls 38 or other similar blunt structure are formed on the free ends of legs 36 to prevent injury to the uterine wall. In addition, by the construction described, the coiled portions of spring members 32 lie in parallel planes, tangent to tube 14 whereby they are relatively fiat against tube 14 and provide a compact, safe assembly. It is also noted that any corrodable or otherwise objectionable metal parts of the medicator i.e., the spring, are suitably coated with a benign material such as Silastic.

In FIG. 4 there is illustrated an applicator 40 containing medicator prior to insertion in the uterus through the vaginal canal. Applicator 40 includes cylindrical tube 42 which receives medicator 10 and maintains spring members 32 in a compressed state during insertion. A plunger member 44 is also provided which is slidable within tube 42 upon actuation of handle 46. Medicator 10 remains in applicator 40 in the condition shown in FIG. 4, during the insertion operation. When the proper uterine position is achieved, plunger 44 is actuated by movement of handle 46 to push medicator 10 through the open top of tube 42 until arms 36 are freed to spring open to their uncompressed state and engage the uterine wall. In this manner medicator 10 is lodged in place and applicator 40 is then withdrawn.

The intrauterine medicator of the present invention may be constructed in a somewhat modified form as shown in FIG. 5. In this embodiment a cylindrical medicator 50, including a tube 52 closed at its opposed ends by plates 54, has a plurality of perforations 56 located intermediate the ends thereof. A column of medication, conveniently in pellet form 55, is retained as in the prior embodiment within tube 52 between a pair of elastic members such as springs 58, which serve to maintain the central portion of the column adjacent perforations 56. Springs 58 act in compression and are contained between end plates 54 and the ends of column 55. Bearing plates 60, similar to plate 30 of the prior embodiment, are provided so that springs 58 do not damage the endmost pellets of medication.

Spring retaining means 62, similar to spring retaining means 12 of the prior embodiment, are provided on the exterior surface of medicator 50 to retain the device in the uterus during use.

The dual spring construction of the embodiment illustrated in FIG. 5 provides a shorter working distance for spring members 58 so that a generally uniform force is applied to the column of medication as it dissolves during use. Thus, variations in the forces applied by springs 58, due to their spring constants and the distance over which they act, are minimized.

While certain preferred embodiments of the intrauterine medicator of the present invention are intended, as disclosed above, to be self-contained units adapted to provide complete antifertility protection, it is foreseen that this medicator may be utilized to supplement presently available intrauterine contraceptive devices, i.e., the well-known IUD.

It is known in the prior art that the presence of foreign objects in the uterus discourages conception, and it has been found that the larger an IUD is, the more effective it is in preventing conception. The employment of such devices, however, is subject to a number of disadvantages, particularly as their size is increased. The more common problems involve discomfort, bleeding, muscular spasms tending to eject the IUD from the uterus, and danger of puncturing the uterine wall during insertion. Each of these problems may be substantially avoided by decreasing the size of the IUD, with a resultant loss, however, in its elfectiveness. It is foreseen that this loss can be compensated by supplementing an IUD with the medicator of the present invention to increase its effectiveness.

In FIG. 6, there is illustrated an intrauterine contraceptive device 70 having an intrauterine medicator 72, similar in construction to the medicator l0 disclosed in FIG. 1. IUD 70 is formed in the general shape of a 7, including a transverse arm 74 having a downwardly concave flexure 76 substantially at its midpoint and a longitudinally extending arm 78 depending from one end 77 of arm 74. Medicator 72 is formed integrally in arm 78 to supplement the contraceptive effects of the device. Both IUD 70 and medicator 72 may be formed of a rigid but flexible physiologically inert material, commonly a plastic such as polyethylene, polypropylene, nylon, Silastic, Dacron,"or the like.

The device is retained in the uterus in part by the lateral pressure exerted by the resilient material of the device around the flexure 76 which tends to engage the ends of transverse arm 74 into the uterine wall. Accordingly, the spring retaining means 12 of the prior embodiments are not required to retain medicator 72 in the uterus, and additionally, the entire device may be decreased in size as medicator 72 will supplement the contraceptive effects of arms 74 and 78.

While only one form of IUD has been illustrated in FIG. 6, and described above, it is foreseen that the medicator of the present invention may be used in combination with other wellknown configurations of IUDs.

The above description of the invention is intended to be illustrative only, and various changes and modifications in the embodiment described may occur to those skilled in the art. These changes may be made without departing from the scope of the invention, and thus it should be apparent that the invention is not limited to the specific embodiments described or illustrated in the drawings.

What is claimed is:

1. A device for the controlled release of a biologically active solid substance in the uterus, said device comprising a supply of said substance and a container therefor, said container being adaptable to containment within the uterine cavity and having perforations in a wall thereof, means within said container for urging said supply of solid substance into the vicinity of said perforations, and resilient retaining means affixed to an external wall of said container for retaining said device within the uterine cavity.

2. A device as defined in claim 1 wherein said solid substance is an antifertility agent.

3. A device as defined in claim 1 wherein said antifertility agent is progesterone.

4. A device as in claim 1 wherein said biologically active substance is in the form of pellets.

5. A device as defined in claim 1 wherein said retaining means comprises, a pair of spring members mounted on said container, each of said spring members having a first end portion fixed to said container and an angularly related second end portion adapted to engage the uterine walls.

6. A device as defined in claim 1 wherein said retaining means comprises a first transverse arm and a second arm coplanar with said first am and dependent therefrom, said second arm including said container.

7. An intrauterine medicator device for the controlled release of biologically active materials, said device comprising a container for said materials adaptable to containment within the uterine cavity and having an elongated generally cylindrical side wall and opposed end wall members, said side wall having a plurality of perforations therein, a column of biologically active material retained within said container and adapted to be released through said perforations into the uterus, means within said container for urging said material towards said perforations and maintaining a supply thereof adjacent said perforations, and resilient retaining means affixed to an external wall of said container for retaining said device within the uterine cavity.

8. A device as defined in claim 7 wherein said perforations are formed in said side wall at locations substantially intermediate said end walls, and said means for urging said material towards said perforations comprises a compression spring positioned within said container at each end thereof for bearing engagement with its associated end wall and the opposed end of said column whereby the central portion of said column is maintained adjacent said perforations during release of said material.

9. A device as defined in claim 7 wherein said perforations are formed in said side wall at one end thereof, and said means for urging said material towards said perforations comprises a compression spring positioned within said container in bearing relation between the other of said end walls and one end of said column to maintain the other end of said column adjacent said perforations and against said one wall during release of said biologically active material.

10. An intrauterine medicator device comprising, in combination, a generally cylindrical tube having closed end portions and formed of an inert material, said tube having a plurality of perforations adjacent one end portion thereof, a column of individual pellets of biologically active material contained within said tube, a compression spring positioned in said tube in bearing relation between the other end portion of 5 said tube and one end of said column to urgesaid column towards said one end and to continuously maintain a portion of said column adjacent said perforations, a pair of spring members mounted on said container, each of said spring members having a first end portion fixed on said container and extending parallel to the longitudinal axis thereof and a second end portion diverging at an acute angle from said first portion adapted to engage the uterine walls to retain said device in the 

1. A device for the controlled release of a biologically active solid substance in the uterus, said device comprising a supply of said substance and a container therefor, said container being adaptable to containment within the uterine cavity and having perforations in a wall thereof, means within said container for urging said supply of solid substance into the vicinity of said perforations, and resilient retaining means affixed to an external wall of said container for retaining said device within the uterine cavity.
 2. A device as defined in claim 1 wherein said solid substance is an antifertility agent.
 3. A device as defined in claim 1 wherein said antifertility agent is progesterone.
 4. A device as in claim 1 wherein said biologically active substance is in the form of pellets.
 5. A device as defined in claim 1 wherein said retaining means comprises, a pair of spring members mounted on said container, each of said spring members having a first end portion fixed to said container and an angularly related second end portion adapted to engage the uterine walls.
 6. A device as defined in claim 1 wherein said retaining means comprises a first transverse arm and a second arm coplanar with said first arm and dependent therefrom, said second arm including said container.
 7. An intrauterine medicator device for the controlled release of biologically active materials, said device comprising a container for said materials adaptablE to containment within the uterine cavity and having an elongated generally cylindrical side wall and opposed end wall members, said side wall having a plurality of perforations therein, a column of biologically active material retained within said container and adapted to be released through said perforations into the uterus, means within said container for urging said material towards said perforations and maintaining a supply thereof adjacent said perforations, and resilient retaining means affixed to an external wall of said container for retaining said device within the uterine cavity.
 8. A device as defined in claim 7 wherein said perforations are formed in said side wall at locations substantially intermediate said end walls, and said means for urging said material towards said perforations comprises a compression spring positioned within said container at each end thereof for bearing engagement with its associated end wall and the opposed end of said column whereby the central portion of said column is maintained adjacent said perforations during release of said material.
 9. A device as defined in claim 7 wherein said perforations are formed in said side wall at one end thereof, and said means for urging said material towards said perforations comprises a compression spring positioned within said container in bearing relation between the other of said end walls and one end of said column to maintain the other end of said column adjacent said perforations and against said one wall during release of said biologically active material.
 10. An intrauterine medicator device comprising, in combination, a generally cylindrical tube having closed end portions and formed of an inert material, said tube having a plurality of perforations adjacent one end portion thereof, a column of individual pellets of biologically active material contained within said tube, a compression spring positioned in said tube in bearing relation between the other end portion of said tube and one end of said column to urge said column towards said one end and to continuously maintain a portion of said column adjacent said perforations, a pair of spring members mounted on said container, each of said spring members having a first end portion fixed on said container and extending parallel to the longitudinal axis thereof and a second end portion diverging at an acute angle from said first portion adapted to engage the uterine walls to retain said device in the uterus, whereby body fluids leach said biologically active material through said perforations for local application to said uterine walls.
 11. A device as defined in claim 10 wherein said second end portions of said spring members lie in parallel planes, tangent to said tube and extend in generally opposite directions whereby said spring members form an inverted V-shaped retaining means.
 12. A device as defined in claim 11 including, a bearing pad positioned between said compression spring and one end of said column. 